Treatment of headaches by electrical stimulation

ABSTRACT

A system is provided that includes a patch, which includes a plurality of electrodes and is configured to be coupled to a subject; and a mobile device, including a computer processor configured to: obtain a physical location of the subject; obtain, from a remote service, a migraine-related forecast specific to the physical location of the subject; enrich the migraine-related forecast with treatment-related statistics collected from a plurality of other subjects to whom electrostimulation treatment has been applied; present the migraine-related forecast on the mobile device; receive an input from a subject; and in response to the input, while the patch is coupled to the subject, wirelessly communicate a control signal that causes the electrodes to apply stimulation to the subject. Other embodiments are also described.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. application Ser. No.15/542,553, filed Jul. 10, 2017, now U.S. Pat. No. 10,213,602, which isthe US national phase of International application PCT/IB2016/050104,filed Jan. 11, 2016, which claims the benefit of U.S. Provisionalapplication 62/102,606, filed Jan. 13, 2015, whose disclosure isincorporated herein by reference.

FIELD OF THE INVENTION

The present application relates to the field of transcutaneouselectrical stimulation.

BACKGROUND

Migraine is a common neurovascular disorder manifesting itself inattacks of headaches that can reach a level of severe pain in manypatients, leading to substantial functional impairment. The recentGlobal Burden of Disease Study 2010 (GBD2010), conducted by the WorldHealth Organization, estimates a worldwide prevalence of migraine of14.7%, ranking it third place among the most common diseases, seventhplace among specific causes of disability, and top among neurologicaldisorders as cause of total years lived with disability. Migraine, thus,affects millions of people. To date, the pathophysiology of migraine isnot fully understood. The current approach to migraine treatment ispredominantly pharmacological.

U.S. Pat. No. 8,340,771, whose disclosure is incorporated herein byreference, describes, according to one aspect, a method of treating apatient by electrically stimulating a predetermined site to treat aneurological condition. The method includes implanting a lead intosubcutaneous tissue of the C2 dermatome/C3 dermatome area.

US Patent Publication 2014/0222102, whose disclosure is incorporatedherein by reference, describes an application downloadable to a mobiledevice for facilitating muscle therapy, the applicable programmed andconfigurable to generate waveform signals, the waveform signalsconfigured to be employed by a power circuit to generate energy,conforming to the signals, to a muscle pad. The application may becombined as a system with a muscle pad electrically interfacing with thedownloadable application, as well as a discrete device in electricalcommunication with the mobile device and the muscle pad. A power circuitand a muscle metric feedback circuit are contemplated as part ofembodiments of a system or kit.

US Patent Publication 2014/0194946, whose disclosure is incorporatedherein by reference, describes a TENS apparatus that includes a portableTENS device having a housing with a lower surface, a pair of integralelectrodes that are incorporated in the lower surface of the housing,and a pulse driver that is located within the housing and adapted togenerate a program of pulse waveforms, each of which is an asymmetricalbiphasic square waveform.

U.S. Pat. No. 8,880,173, whose disclosure is incorporated herein byreference, describes a device for providing transdermal electricalstimulation at an adjustable position on a head. The device includes asupporting member economically shaped and configured to be fixedlysupported about an anatomical body part; the supporting member beingadjustably positionable in only two directions substantiallyperpendicular to one another. No electrical stimulation is provided bythe supporting member. Alternatively, the device includes at least onepair of electrodes for producing the transdermal electrical stimulationto the head. The electrodes are mounted to a securing member shaped andconfigured to be releasably securable only about a plurality of strandsof hair at a predetermined fixed orientation without being secured aboutany anatomical body part.

U.S. Pat. No. 8,805,548, whose disclosure is incorporated herein byreference, describes a headband for use in neurostimulation made atleast partly of elastic or stretch material comprising: a hole to belocated directly on the rear part of the scalp of a user, said holebeing sized to fit the inion or occipital protuberantia; at least twoelectrodes directly attached to the headband and positioned adjacent toand symmetric about said hole, designed so that to be applied on theright and left branch of the occipital nerve respectively, once theinion is put in correspondence with said hole by the user; a connectorfor connecting a wearable neurostimulator to the headband, saidconnector being located opposite to said hole, once the headband is wornby the user and means coupled to the elastic or stretch material forelectrically connecting said connector and each of said electrodes.

U.S. Pat. No. 8,428,734, whose disclosure is incorporated herein byreference, describes a device for the electrotherapeutic treatment ofheadaches such as tension headaches and migraines. An electrode supporthas a shape and is size selected so as to allow, independently from thesubject, the excitation of the afferent paths of the supratrochlear andsupraorbital nerves of the ophthalmic branch of the trigeminal nerve. Anelectrical circuit includes a programmable signal generator suitable forcreating pulses of a duration of between 150 and 450 microseconds with amaximum increase in intensity of 0 to 20 milliamperes at a rate of lessthan or equal to 40 microamperes per second and with a step up inintensity not exceeding 50 microamperes.

U.S. Pat. No. 8,874,205, whose disclosure is incorporated herein byreference, describes a non-invasive electrical stimulation device thatshapes an elongated electric field of effect that can be orientedparallel to a long nerve, such as a vagus nerve in a patient's neck,producing a desired physiological response in the patient. Thestimulator comprises a source of electrical power, at least oneelectrode and a continuous electrically conducting medium in which theelectrode(s) are in contact. The stimulation device is configured toproduce a peak pulse voltage that is sufficient to produce aphysiologically effective electric field in the vicinity of a targetnerve, but not to substantially stimulate other nerves and muscles thatlie between the vicinity of the target nerve and patient's skin. Currentis passed through the electrodes in bursts of preferably five sinusoidalpulses, wherein each pulse within a burst has a duration of preferably200 microseconds, and bursts repeat at preferably at 15-50 bursts persecond.

U.S. Pat. No. 8,874,227, whose disclosure is incorporated herein byreference, describes a non-invasive electrical stimulator that shapes anelongated electric field of effect that can be oriented parallel to along nerve, such as a vagus nerve in a patient's neck, producing adesired physiological response in the patient. The stimulator comprisesa source of electrical power, at least one electrode and a continuouselectrically conducting medium in contact with the electrodes. Theconducting medium is also in contact with an interface element that mayconform to the contour of a target body surface of the patient when theinterface element is applied to that surface. When the interface elementis made of insulating (dielectric) material, and disclosed stimulationwaveforms are used, the power source need not supply high voltage, inorder to capacitively stimulate the target nerve. The stimulator isconfigured to produce a peak pulse that is sufficient to produce aphysiologically effective electric field in the vicinity of a targetnerve, but not to substantially stimulate other nerves and muscles thatlie in the vicinity of the target nerve and patient's skin.

Slavin, Konstantin V., Hrachya Nersesyan, and Christian Wess.“Peripheral neurostimulation for treatment of intractable occipitalneuralgia.” Neurosurgery 58.1 (2006): 112-119, which is incorporatedherein by reference, describes chronic peripheral nerve stimulation forlong-term treatment of chronic pain syndrome in patients with medicallyintractable occipital neuralgia.

Ristić, Dejan, and Jens Ellrich. “Innocuous peripheral nerve stimulationshifts stimulus-response function of painful laser stimulation in man.”Neuromodulation: Technology at the Neural Interface 17.7 (2014):686-695, which is incorporated herein by reference, describes electricalperipheral nerve stimulation as an effective neuromodulatory treatmentin chronic pain.

Nir, Rony-Reuven, et al. “A psychophysical study of endogenousanalgesia: the role of the conditioning pain in the induction andmagnitude of conditioned pain modulation.” European Journal of Pain 15.5(2011): 491-497, which is incorporated herein by reference,experimentally examines endogenous analgesia using a conditioned painmodulation paradigm.

Burstein, Rami, Michael F. Cutrer, and David Yarnitsky. “The developmentof cutaneous allodynia during a migraine attack clinical evidence forthe sequential recruitment of spinal and supraspinal nociceptive neuronsin migraine.” Brain 123.8 (2000): 1703-1709, which is incorporatedherein by reference, studied the way in which cutaneous allodyniadevelops by measuring the pain thresholds in the head and forearmsbilaterally at several time points during a migraine attack in a42-year-old male.

SUMMARY OF THE INVENTION

There is provided, in accordance with some embodiments of the presentinvention, a system for electrostimulation. The system includes a patch,including a plurality of electrodes, and a mobile device. A processor ofthe mobile device is configured to receive an input from a subject thatindicates that the subject is experiencing a headache, and, in responseto the input, while the patch is coupled to the subject, wirelesslycommunicate a control signal that causes the electrodes to stimulate thesubject.

In some embodiments, the processor is further configured to:

obtain a physical location of the subject, and

in response thereto, present, on the mobile device, a migraine-relatedforecast that is specific to the physical location of the subject.

There is further provided, in accordance with some embodiments of thepresent invention, a method for treating a headache. A plurality ofelectrodes are coupled to a subject, caudally to a neck of the subject.In response to the subject experiencing a headache, using the coupledelectrodes, without using any element that is implanted in the subject,and without using any element that penetrates skin of the subject, theheadache is treated, by transcutaneously stimulating the subject.

In some embodiments, coupling the electrodes caudally to the neck of thesubject includes coupling the electrodes to an arm of the subject.

In some embodiments, coupling the electrodes to the arm of the subjectincludes coupling the electrodes to an upper arm of the subject.

In some embodiments, coupling the electrodes to the arm of the subjectincludes coupling the electrodes transversely to the arm of the subject.

In some embodiments, transcutaneously stimulating the subject includestranscutaneously stimulating the subject by applying, to the subject, aplurality of electrical pulses.

In some embodiments, applying the electrical pulses includes applyingthe electrical pulses at a non-constant rate.

In some embodiments, applying the electrical pulses includes applyingthe electrical pulses at a rate of between 100 and 120 pulses persecond.

In some embodiments, each of the electrical pulses has a duration ofbetween 90 and 410 microseconds.

In some embodiments, transcutaneously stimulating the subject includestranscutaneously stimulating the subject for a total duration of between1200 and 2600 seconds.

In some embodiments, the electrodes are coupled to an adhesive patch,and coupling the electrodes to the subject includes adhering theadhesive patch to the subject.

In some embodiments, the method further includes wirelesslycommunicating a control signal that causes the coupled electrodes totranscutaneously stimulate the subject.

In some embodiments, wirelessly communicating the control signalincludes wirelessly communicating the control signal from a mobiledevice.

In some embodiments, the mobile device includes a mobile phone.

In some embodiments, the headache is a migraine headache.

In some embodiments, transcutaneously stimulating the subject includestranscutaneously stimulating the subject within two hours of the subjectbeginning to experience the headache.

In some embodiments, the method further includes controlling thestimulation of the subject in response to feedback received from theelectrodes.

In some embodiments, the feedback includes an impedance measurement, andcontrolling the stimulation of the subject includes controlling thestimulation of the subject in response to the impedance measurement.

In some embodiments, the feedback includes an electromyographicalmeasurement, and controlling the stimulation of the subject includescontrolling the stimulation of the subject in response to theelectromyographical measurement.

In some embodiments, transcutaneously stimulating the subject includestranscutaneously stimulating the subject using stimulation parametersderived by processing results of electrostimulation treatment of aplurality of other subjects.

There is further provided, in accordance with some embodiments of thepresent invention, a computer software product including a tangiblenon-transitory computer-readable medium in which program instructionsare stored. The instructions, when read by a processor of a mobiledevice, cause the processor to receive an input from a subject thatindicates that the subject is experiencing a headache, and, in responseto the input, wirelessly communicate a control signal that causes aplurality of electrodes coupled to the subject to transcutaneouslystimulate the subject.

In some embodiments, the input is a first input, and the instructionsfurther cause the processor to receive one or more second inputsregarding a level of pain experienced by the subject, and, in responseto the one or more second inputs, generate an output.

The present invention will be more fully understood from the followingdetailed description of embodiments thereof, taken together with thedrawings, in which:

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic illustration of a method for treating a headache,in accordance with some embodiments of the present invention.

DETAILED DESCRIPTION OF EMBODIMENTS Overview

Transcutaneous electrical stimulation (or transcutaneous“electrostimulation”) is a non-invasive technique that delivers asequence of weak electrical pulses to a subject's skin. “Weak,” in thiscontext, means that the intensity of the pulses is typically below thepain threshold of the subject. Electrical stimulation is widely used totreat painful conditions, by the application of the above-mentioned weakpulses to the painful region of the body.

The present inventors have discovered that transcutaneouselectrostimulation may be used to treat headaches, such as migraineheadaches or tension headaches, even if the stimulation is not appliedin the immediate vicinity of the painful region of the subject's body.For example, the stimulation may be applied caudally to the subject'sneck, i.e., below the subject's neck, such as on the subject's torso, oron an arm or leg of the subject. The ascending stimulus-induced activityevokes descending pathways, which, in turn, exert modulatory effects onincoming nociceptive inputs, modifying the degree to which the headacheis perceived. This underlying phenomenon, known as conditioned painmodulation, is described in the above-referenced article by Nir et al.,which is incorporated herein by reference.

Further to the aforementioned discovery, embodiments of the presentinvention treat headaches, by delivering transcutaneouselectrostimulation caudally to the neck of the subject. Typically, uponexperiencing a headache, the subject adheres an adhesive patch to asuitable part of the subject's body, such as the subject's upper arm.The subject then uses a mobile device, such as the subject's mobilephone, to communicate a control signal that causes electrodes on thepatch to deliver electrical stimuli to the subject.

The techniques described herein are particularly effective in treatingmigraine headaches. As described in the above-cited article to Bursteinet al., the nociceptive pathways associated with the migraine headacheundergo a process of sensitization during, approximately, the first twohours following the onset of the headache. Hence, by deliveringelectrostimulation treatment during these first two hours, the migraineheadache may be aborted, or at least become reduced in severity.

As described below, clinical data collected by the inventors provideevidence that techniques described herein provide effective relief,without causing pain or other adverse side effects.

Another advantage of embodiments of the present invention is that theprovided treatment is performed entirely non-invasively. In other words,no implanted or skin-penetrating element—i.e., no implanted orskin-penetrating device or any part of any device—is used to deliver thetreatment. Moreover, since treatment is delivered caudally to the neck,rather than nearer to the actual pain site, embodiments described hereinare significantly safer than some other methods that have beendescribed. For example, methods that stimulate the trigeminal or vagusnerve (which are near the head) risk impacting important functions suchas facial sensation, biting, chewing, heart rate, sweating, and speech.Embodiments described herein, on the other hand, do not run this risk.

Moreover, the patch is typically relatively small and disposable, anddoes not include cumbersome wired connections external to the patch.Hence, the patch may be worn for prolonged periods, and repeatedlyactivated when needed.

METHOD DESCRIPTION

Reference is initially made to FIG. 1, which is a schematic illustrationof a method for treating a headache experienced by a subject 20, inaccordance with some embodiments of the present invention.

To treat the headache, subject 20 first couples a plurality ofelectrodes to, for example, an arm of the subject. For example, as shownin the FIGURE, the subject may adhere a flexible adhesive patch 22 toher upper arm, adhesive patch 22 having a plurality of electrodes 24 aand 24 b coupled to the underside thereof. Subsequently, the electrodestranscutaneously stimulate the subject, by delivering electrical stimulito the subject.

In some embodiments, as shown in the FIGURE, the electrodes are coupledtransversely to the upper arm of the subject. In other embodiments, theelectrodes are coupled proximally-distally, e.g., by adhering patch 22in an orientation that is rotationally offset by 90 degrees from theorientation shown in FIG. 1. In yet other embodiments, otherorientations may be used. In some embodiments, rather than adhering apatch to the subject, the subject wears a cuff, sleeve, or wrap aroundthe subject's arm or leg, the cuff, sleeve, or wrap having a pluralityof electrodes coupled thereto.

In some embodiments, the electrodes are coupled to a single dermatome.In other embodiments, the electrodes are spread over a plurality ofdermatomes. Generally, factors that affect which dermatomes arestimulated include the size of the patch, the position and orientationof the patch, and the position of the electrodes on the patch.

Typically, an electronics module 26 contained within the patch controlsthe electrodes, in response to control signals, which are typicallywirelessly received. Electronics module 26 typically comprises a powersource, a central processing unit (CPU), typically programmed inmicrocode, that controls the electrodes, one or more memory units forstoring the stimulation sequences during the stimulation, an impulsegenerator, and components for wireless communication, based on BluetoothLow Energy (BLE) technology, for example. In some embodiments, theelectronics module is an integrated system-on-chip (SoC).

Although only two electrodes are shown in FIG. 1, it is noted that anysuitable number of electrodes may be used, sequentially or concurrently,to deliver electrostimulation pulses. Moreover, some of the electrodescoupled to the subject may be used for sensing, alternatively oradditionally to being used for electrostimulation. For example, a singleelectrode pair may perform both stimulating and sensing functions. Inresponse to the sensing, the electrodes provide feedback signals to theCPU. In response thereto, the CPU may automatically control thetreatment, and/or transmit the feedback to a mobile device (as describedbelow), which, in turn, may automatically control the treatment.

Typical sensing functions include the monitoring of electrode-skinimpedance, as described, for example, in U.S. application Ser. No.14/992,046, filed Jan. 11, 2016, which issued as U.S. Pat. No. 9,895,533and is incorporated herein by reference. Such monitoring enhances thecomfort and safety of the subject, by allowing the detection ofelectrode peel-off, and/or abnormal physiological reactions, such asexcessive sweating. In response to impedance-related feedback from theelectrodes, the treatment may be interrupted.

Alternatively or additionally, electromyographical sensing may be usedto help set the appropriate stimulation intensity. For example, ifmuscle contractions are detected, the intensity may be automaticallyreduced, and/or the subject may be prompted (e.g., via a dedicatedapplication running on the subject's mobile device) to reduce theintensity or re-position the patch.

Typically, as shown in the FIGURE, the electrodes begin to stimulate thesubject in response to a wireless control signal, such as a wirelesscontrol signal from a mobile device 28. Upon receiving the controlsignal, the electronics module drives the electrodes to beginstimulating the subject.

In some embodiments, mobile device 28 comprises a smartphone or tabletcomprising a processor 30, which is typically a programmed digitalcomputing device comprising a central processing unit (CPU), randomaccess memory (RAM), non-volatile secondary storage, such as a harddrive, network interfaces, and/or peripheral devices. Program code,including software programs, and/or data are loaded into the RAM forexecution and processing by the CPU and results are generated fordisplay, output, transmittal, or storage, as is known in the art. Theprogram code and/or data may be downloaded to the processor inelectronic form, over a network, for example, or it may, alternativelyor additionally, be provided and/or stored on non-transitory tangiblemedia, such as magnetic, optical, or electronic memory. Such programcode and/or data, when provided to the processor, produce a machine orspecial-purpose computer, configured to perform the tasks describedherein.

For example, a dedicated application running on the mobile device mayprovides program instructions which, when read by processor 30, causeprocessor 30 to perform the various tasks described herein. (Forsimplicity, the present description may refer to various tasks performedby the processor in response to such program instructions as beingperformed by “the application,” “the dedicated application,” or “themobile application.”) Typically, such an application providesinstructions that cause the processor to receive an input from thesubject that indicates that the subject is experiencing a headache, and,in response to the input, communicate the control signal to theelectronics module.

In some embodiments, the dedicated application further allows thesubject to choose a particular treatment program, and/or controlstimulation parameters, such as the intensity of the stimulation.Alternatively or additionally, the application may monitor thetreatment, by receiving feedback from the electrodes. In response to thefeedback, the application may change the treatment program, adjuststimulation parameters (e.g., by adjusting the stimulation intensity inresponse to electromyographical feedback), or terminate the treatment(e.g., in response to the feedback indicating an abnormally highimpedance at the electrode-skin interface).

In some embodiments, the application alternatively or additionally logsactivity associated with the treatment, monitors historical activity,generates customized treatment programs, and/or generates customizedreports for viewing by the subject and/or the subject's physician. Insome embodiments, the application retrieves data from, and/or writesdata to, the subject's electronic health records. Alternatively oradditionally, the application may send data to a server for additionalanalysis, and/or for integration with existing data repositories, e.g.,to expand collective knowledge. For example, the application maytransmit the respective location of, and statistics related to, eachtreatment session, and such data may then be used to improve theaccuracy of, and/or enrich the content of, location-specific migraineforecasts, as further described hereinbelow.

In some embodiments, the application updates the treatment programsoffered to the subject, in response to receiving collective “wisdom ofthe crowd” feedback or information based on “big data” processing. Forexample, a remote server may process results from electrostimulationtreatment of a plurality of other subjects, and the application may use,as the default stimulation parameters, stimulation parameters(including, for example, an intensity or duration of stimulation)derived from such processing.

In some embodiments, the application collects feedback from the subject.For example, the application may query the subject regarding thesubject's level of pain prior to treatment, during the treatment,immediately following treatment, and/or some time after treatment (e.g.,two hours post-treatment). Such feedback may be used to generate anyrelevant output, such as a customized report as described above, anoutput that recommends a particular adjustment of treatment parameters,or a control signal that adjusts the treatment parameters.

In some embodiments, the mobile application obtains, with the subject'sapproval, the subject's physical location coordinates, e.g., using aGlobal Positioning System (GPS) service. The application then obtains amigraine-related forecast, which is specific to the subject's location,from a relevant service, such as the AccuWeather.com Migraine HeadacheForecast. The application may then present the forecast to the subject,thus informing the subject of the probability that the subject willexperience a migraine attack during an upcoming period of time, e.g.,during the next day and/or week. The application may enrich such amigraine forecast with treatment-related statistics collected from aplurality of subjects, as described above. For example, the applicationmay increase the risk level for the subject's location if a relativelylarge number of treatments have recently been recorded in the subject'slocation.

Alternatively or additionally, the mobile application may generatevarious warnings, alerts, reminders, or other types of output, which maybe delivered to the subject in audio and/or visual form. For example, inresponse to a threatening migraine forecast, the mobile application maysuggest that the subject remain at home on a particular day, or at leastrefrain from traveling to a particular location. Alternatively oradditionally, in response to a threatening forecast, the mobileapplication may remind the subject to bring along the subject's patch,in case treatment will be required.

Alternatively or additionally, if the power source within electronicsmodule 26 is running low, the application may remind the subject torecharge the power source, or obtain a new patch.

Typically, as noted above, electronics module 26 comprises one or morememory units, such as Random Access Memory (RAM) units. The memory unitsstore the stimulation sequences during the stimulation, such that themobile device need not necessarily remain in communication with thepatch during the treatment.

In some embodiments, to establish the connection between device 28 andpatch 22, the subject inputs an identifying field, such as a username,to the device. Alternatively or additionally, the device may identifythe patch by scanning a barcode or other suitable identifier on thepatch, and/or by capturing an image of the patch and identifying thepatch in the image.

In some embodiments, patch 22 may be additionally used for thecontrolled delivery of medications, such as pain relief medications orantidepressants. The application running on device 28 may control suchdelivery, in response to feedback from the electrodes.

In some embodiments, the above-described techniques are used to preventthe onset of headaches, before any pain is sensed by the subject. Forexample, a customized electrostimulation treatment as described abovemay be delivered at regular intervals, e.g., daily. The dedicatedapplication on mobile device 28 may facilitate the scheduling of suchtreatments, and/or may automatically alert the subject when necessary,in order to facilitate compliance with the treatment schedule.

Stimulation Parameters

Although the scope of the present disclosure includes using any relevantstimulation parameters, the present inventors have found that certainstimulation parameters may be particularly effective in treatingmigraine headaches.

One parameter is the rate (or “frequency”) at which the plurality ofelectrical pulses are applied to the subject. The inventors have foundthat a rate of between 100 and 120 pulses per second (which may beexpressed as a frequency of between 100 and 120 Hz) may be particularlyeffective. In some embodiments, the electrical pulses are applied at anon-constant rate. For example, the rate of pulse delivery may varywithin the range of between 100 and 120 pulses per second over thecourse of the stimulation. Such variation in pulse rate may help preventhabituation of the central nervous system to the stimulation.

Another parameter is the duration (or “width”) of each pulse. Theinventors have found that a pulse duration of between 90 and 410microseconds may be particularly effective. In particular, the inventorshave defined three stimulation programs, each of which uses a differentrespective pulse duration: “program 1” uses a pulse duration of 200microseconds, “program 2” uses 300 microseconds, and “program 3” uses400 microseconds. Each of the above programs has a total stimulationduration of 1200 to 2600 seconds, and a pulse rate that varies in therange of between 100 and 120 pulses per second.

Typically, the pulse duration does not vary over the course of thestimulation. Each pulse typically has a symmetric, square shape,comprising positive and negative portions of equal duration. Thus, forexample, in program 1, each of the positive and negative portions ofeach pulse has a duration of 100 microseconds.

Another parameter is the intensity of the pulses. This parameter istypically set separately by and/or for each subject, such that eachsubject is stimulated at an intensity that is slightly below thesubject's pain threshold. As described above, the dedicated applicationrunning on mobile device 28 may help set the intensity, by receivingrelevant feedback from the subject.

Clinical Data

In a study performed at Rambam Hospital, Haifa, Israel, a plurality ofsubjects were treated for migraine headaches, using techniques describedherein. In particular, 129 treatments were performed using program 3 asdefined above, 54 treatments were performed using program 2, and 46treatments were performed using program 1. 35 placebo treatments werealso performed. The results for program 3 are presented below. (Forsimplicity, the results for the other two programs—which, like theresults for program 3, reflect favorably on the presently-disclosedtechniques—are not included in the present disclosure.)

For 42% of treatments (vs. only 29% for the placebo), the treatedsubject reported significant pain relief two hours after treatment. For17% of treatments (vs. only 9% for the placebo), the treated subjectreported complete pain relief two hours after treatment. Moreover, 34%of the 32 treated subjects (vs. only 7% of the 15 placebo-treatedsubjects, and only 29% of subjects treated with Sumatriptan, a commonmedication used for migraine treatment) reported, on average, completepain relief two hours after treatment.

It will be appreciated by persons skilled in the art that the presentinvention is not limited to what has been particularly shown anddescribed hereinabove. Rather, the scope of the present inventionincludes both combinations and subcombinations of the various featuresdescribed hereinabove, as well as variations and modifications thereofthat are not in the prior art, which would occur to persons skilled inthe art upon reading the foregoing description. Documents incorporatedby reference in the present patent application are to be considered anintegral part of the application except that to the extent any terms aredefined in these incorporated documents in a manner that conflicts withthe definitions made explicitly or implicitly in the presentspecification, only the definitions in the present specification shouldbe considered.

The invention claimed is:
 1. A system comprising: a patch, whichcomprises a plurality of electrodes and is configured to be coupled to asubject; and a mobile device, comprising a computer processor configuredto: obtain a physical location of the subject, obtain, from a remoteservice, a migraine-related forecast specific to the physical locationof the subject, enrich the migraine-related forecast withtreatment-related statistics collected from a plurality of othersubjects to whom electrostimulation treatment has been applied, presentthe migraine-related forecast on the mobile device, receive, from aremote server, stimulation parameters derived from processing by theremote server of results from electrostimulation treatment of aplurality of other subjects, receive an input from a subject, and inresponse to the input, while the patch is coupled to the subject,wirelessly communicate a control signal that causes the electrodes toapply stimulation to the subject using the received stimulationparameters as default stimulation parameters for the stimulation.
 2. Thesystem according to claim 1, wherein the computer processor isconfigured to increase the risk level for the subject's location if arelatively large number of treatments have recently been recorded in thesubject's location.
 3. The system according to claim 1, wherein thereceived stimulation parameters are selected from the group ofparameters consisting of: an intensity of the stimulation and a durationof the stimulation.
 4. A method comprising: coupling a patch, whichincludes a plurality of electrodes, to a subject; and using a computerprocessor of a mobile device: obtaining a physical location of thesubject, obtaining, from a remote service, a migraine-related forecastspecific to the physical location of the subject, enriching themigraine-related forecast with treatment-related statistics collectedfrom a plurality of other subjects to whom electrostimulation treatmenthas been applied, presenting the migraine-related forecast on the mobiledevice, receiving, from a remote server, stimulation parameters derivedfrom processing by the remove server of results from electrostimulationtreatment of a plurality of other subjects, receiving an input from asubject, and in response to the input, while the patch is coupled to thesubject, wirelessly communicating a control signal that causes theelectrodes to apply stimulation to the subject using the receivedstimulation parameters as default stimulation parameters for thestimulation.
 5. The method according to claim 4, wherein enriching themigraine-related forecast comprises, using the computer processor,increasing the risk level for the subject's location if a relativelylarge number of treatments have recently been recorded in the subject'slocation.
 6. The method according to claim 4, wherein the receivedstimulation parameters are selected from the group of parametersconsisting of: an intensity of the stimulation and a duration of thestimulation.
 7. A system comprising: a patch, which comprises aplurality of electrodes and is configured to be coupled to a subject;and a mobile device, comprising a computer processor configured to:obtain a physical location of the subject, obtain, from a remoteservice, a migraine-related forecast specific to the physical locationof the subject, in response to a threatening migraine forecast, remindthe subject to bring along the patch, in case treatment will berequired, receive, from a remote server, stimulation parameters derivedfrom processing by the remote server of results from electrostimulationtreatment of a plurality of other subjects, receive an input from asubject, and in response to the input, while the patch is coupled to thesubject, wirelessly communicate a control signal that causes theelectrodes to apply stimulation to the subject using the receivedstimulation parameters as default stimulation parameters for thestimulation.
 8. The system according to claim 7, wherein the computerprocessor is configured to present the migraine-related forecast on themobile device.